Doxazosin Neo Teva-Ratiopharm 8 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Doxazosina Neo Teva-ratiopharm 8mg prolonged-release tablets EFG

doxazosin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Doxazosina Neo Teva-ratiopharm is and what it is used for
2. What you need to know before taking Doxazosina Neo Teva-ratiopharm
3. How to take Doxazosina Neo Teva-ratiopharm
4. Possible side effects
5. How to store Doxazosina Neo Teva-ratiopharm
6. Contents of the pack and other information

1. What Doxazosina Neo Teva-ratiopharm is and what it is used for

Your doctor may have prescribed Doxazosina Neo Teva-ratiopharm because you have high blood pressure, which can increase your risk of heart disease or stroke if left untreated. The active substance in the tablets, doxazosin, belongs to a group of medicines called alpha-1 blockers. These medicines work by widening blood vessels, making it easier for the heart to pump blood through them. This helps lower high blood pressure and reduces the risk of heart disease.

Additionally, you may have been prescribed Doxazosina Neo Teva-ratiopharm to treat symptoms of benign enlargement of the prostate (benign prostatic hyperplasia, BPH). This condition means that the prostate, a gland located just below the bladder in men, is enlarged. This can make it difficult to empty the bladder. Doxazosina Neo Teva-ratiopharm works by relaxing the muscles around the outlet of the bladder and the prostate gland, making it easier to empty the bladder.

The doxazosin contained in Doxazosina Neo Teva-ratiopharm may also be approved for treating other conditions not listed in this leaflet. If you have any further questions, ask your doctor, pharmacist, or other healthcare professional, and always follow their instructions.

2. What you need to know before taking Doxazosina Neo Teva-ratiopharm

Do not take Doxazosina Neo Teva-ratiopharm

• If you are allergic to doxazosin, other quinazolines (for example, prazosin, terazosin), or to any of the other ingredients of this medicine (listed in section 6).
• If you have low blood pressure or have ever experienced a drop in blood pressure causing dizziness or fainting upon standing up from a sitting or lying position.
• If you have benign enlargement of the prostate and, at the same time, upper urinary tract obstruction, chronic urinary infection, or bladder stones.
• If you have or have had a blockage or narrowing of the digestive tract.
• If you have overflow urinary incontinence or are unable to pass urine, with or without worsening of kidney function.

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxazosina Neo Teva-ratiopharm

• At the beginning of treatment, you may experience a drop in blood pressure accompanied by dizziness, weakness, and, rarely, fainting. Avoid situations that could lead to injury if you experience these symptoms.
• If you have any acute heart condition, such as heart failure.
• If you have any liver disease. In cases of severe liver disease, the use of Doxazosina Neo Teva-ratiopharm is not recommended.
• If you are also taking medications used to treat erectile problems (PDE-5 inhibitors, e.g., sildenafil, tadalafil, vardenafil), as they may cause a significant decrease in blood pressure. This is most likely to occur shortly after taking the PDE-5 inhibitor. Therefore, treatment with doxazosin should be stable before starting treatment with PDE-5 inhibitors. Your doctor may consider using a lower starting dose of the PDE-5 inhibitor.
• If you are scheduled for cataract eye surgery (clouding of the lens), you must inform your ophthalmologist before surgery that you are currently taking or have previously taken Doxazosina Neo Teva-ratiopharm. This is because Doxazosina Neo Teva-ratiopharm may cause complications during surgery, which can be managed if this information is communicated to the specialist.

During treatment with doxazosin, prolonged and painful erections may very rarely occur. If this happens, consult a doctor immediately.

Occasionally, you may notice something resembling a tablet in your stools. This is normal. The active ingredient in the prolonged-release tablets is contained within a non-absorbable coating, specially designed to slowly release the medicine into the body. Once the process is complete, the empty shell is excreted in the faeces.

Talk to your doctor or pharmacist if you have any doubts.

Children and adolescents

Doxazosina Neo Teva-ratiopharm is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy have not yet been established.

Other medicines and Doxazosina Neo Teva-ratiopharm

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription. Specifically inform your doctor if you are taking any of the following medicines:

• Other alpha-blockers and other medicines used in the treatment of high blood pressure.
• Medicines called PDE-5 inhibitors for the treatment of erectile dysfunction, e.g., sildenafil, tadalafil, vardenafil (see section “Warnings and precautions”).
• Medicines used to treat bacterial or fungal infections, for example, clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Doxazosina Neo Teva-ratiopharm with food, drinks and alcohol

Doxazosina Neo Teva-ratiopharm can be taken with or without food.

Pregnancy and breast-feeding

For the indication of hypertension only:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take Doxazosina Neo Teva-ratiopharm without first talking to your doctor if you are pregnant or trying to become pregnant. Experience with the use of doxazosin during pregnancy is limited.

Breast-feeding

Small amounts of doxazosin, the active substance in Doxazosina Neo Teva-ratiopharm, may pass into breast milk. You should not take Doxazosina Neo Teva-ratiopharm while breast-feeding unless your doctor advises you to do so.

Driving and using machines

Your ability to perform tasks such as operating machinery or driving vehicles may be impaired, especially at the beginning of treatment.

Doxazosina Neo Teva-ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Doxazosina Neo Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

Doxazosina Neo Teva-ratiopharm has been specially formulated to allow slow release of the active substance throughout the day. Choose a time of day that is convenient for you and always take the tablets at that time. The tablets must be swallowed whole with sufficient liquid. They must not be chewed, split, or crushed.

Treatment of high blood pressure and symptoms of benign prostatic hyperplasia:

Adults (including elderly)

The recommended dose of doxazosin is 4 mg of doxazosin per day, although your doctor may increase your dose up to a maximum of 8 mg of doxazosin (one tablet) per day.

The maximum recommended dose is 8 mg of doxazosin once daily. The optimal effect may take up to four weeks to be achieved.

Patients with liver problems

Your doctor may reduce your dose or monitor your condition more closely. Doxazosin is not recommended for use in patients with severe liver problems.

If you take more Doxazosina Neo Teva-ratiopharm than you should

If you take too many tablets or, for example, a child has accidentally taken the medicine, call your doctor immediately, go to the hospital emergency department, or contact the Toxicology Information Service, telephone: 91 562 04 20. If you have taken too many tablets, you may experience dizziness or lightheadedness due to a drop in blood pressure. Lie down on your back with your feet raised, at a higher level than your head.

If you forget to take Doxazosina Neo Teva-ratiopharm

If you forget to take a dose, do not worry. Simply take the next day's dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Doxazosina Neo Teva-ratiopharm

Continue taking the tablets until your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some of these adverse effects could be serious:

If you experience any of the following effects, stop taking this medicine immediately and contact your doctor or go to the nearest hospital emergency department:

• Allergic reactions such as wheezing, difficulty breathing, extreme dizziness or fainting, swelling of the face or throat, or a severe skin rash with red spots or blisters (may affect up to 1 in 100 people).

• Chest pain (angina pectoris; may affect up to 1 in 100 people), increased heart rate or irregular heartbeat (affects fewer than 1 in 10,000 users), cardiac arrest or stroke (may affect up to 1 in 100 people).

• Yellowing of the skin or whites of the eyes (jaundice), caused by liver problems (may affect up to 1 in 10,000 people).

Common adverse effects (may affect up to 1 in 10 people):

• Palpitations (strong heartbeat), increased heart rate.
• Dizziness, headache, drowsiness.
• Feeling of dizziness or that ‘the head is spinning’.
• Inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (nasal itching, runny nose, and nasal congestion).
• Abdominal discomfort, stomach discomfort (dyspepsia), dry mouth, nausea.
• Inflammation of the bladder (cystitis), uncontrolled urination.
• Itchy skin.
• Back pain, muscle pain.
• Lung infection (respiratory tract infection), kidney or bladder infection (urinary tract infection).
• Low blood pressure, sudden drop in blood pressure upon standing.
• Weakness, flu-like symptoms, swelling especially of the feet and lower limbs (edema).

Uncommon adverse effects (may affect up to 1 in 100 people):

• Weight gain.
• Reduced senses, fainting, tremor.
• Tinnitus (ringing in the ears).
• Nosebleeds.
• Constipation, diarrhea, flatulence, vomiting, inflammation of the stomach and intestines.
• Pain during urination, blood in the urine, increased frequency of urination.
• Skin rash.
• Pain and stiffness in the joints (arthralgia).
• Increased or decreased appetite, gout (a painful form of arthritis).
• Pain and swelling, especially of the face (facial edema).
• Increased levels of liver enzymes.
• Inability to achieve an erection.
• Anxiety, depression, insomnia.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Obstruction of the gastrointestinal tract.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Decreased heart rate.
• Decreased concentration of certain blood cells (leukopenia, thrombocytopenia).
• Dizziness upon standing, tingling sensation with numbness.
• Blurred vision.
• Narrowing of the airways causing difficulty breathing or wheezing (bronchospasm).
• Problems with urination, increased need to urinate at night, increased production and volume of urine.
• Hair loss, unusual bleeding or bruising under the skin, rashes.
• Muscle cramps, muscle weakness.
• Hot flushes.
• Fatigue, general malaise.
• Obstruction of bile excretion from the liver (cholestasis), inflammation of the liver (hepatitis).
• Breast enlargement in men.
• Persistent and painful erection. Consult a doctor urgently.
• Restlessness, nervousness.

Adverse effects with unknown frequency (cannot be estimated from available data):

• Complications (Intraoperative Floppy Iris Syndrome) during cataract surgery (see section 2: “Warnings and precautions”).
• Delayed ejaculation – occurs when semen is redirected into the urinary bladder instead of normal ejaculation through the urethra.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosin Neo Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after 'EXP'. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Neo Teva-ratiopharm

The active substance is doxazosin (as mesilate). Each prolonged-release tablet contains 8 mg of doxazosin (as mesilate).

The other components are:

Tablet core: polyethylene oxide (MW 900,000), polyethylene oxide (MW 200,000), microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-α-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate.

Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, colloidal hydrated silica, macrogol 1300-1600, titanium dioxide (E171).

Appearance of the product and contents of the pack

The tablets are white, round and biconvex, with the imprint “DH” on one side.

The medicine is packaged in:

• PVC/PVDC/aluminum blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, or 100 tablets.
• Calendar packs: 7, 14, 28, 56 and 98 tablets.
• Unit dose pack: 50 x 1 tablet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U
c/ Anabel Segura 11, Edificio Albatros B 1st floor
28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Doxazosina-ratiopharm 8 mg Retardtabletten
Austria Doxarutis 8 mg Retardtabletten
Spain Doxazosina Neo Teva-ratiopharm 8 mg prolonged-release tablets EFG
Portugal Doxazosina ratiopharm 8 mg prolonged-release tablets

Date of the most recent review of this leaflet: August 2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74978/P_74978.html

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